Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Solid and Hematological Malignancies

Launched by JABEZ BIOSCIENCE, INC · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called JBZ-001 to see if it is safe and effective for patients with advanced solid tumors or certain types of blood cancers that have not responded to standard treatments. The trial is designed in two parts: the first part will gradually increase the dose of JBZ-001 given to patients to find out the highest dose that is still safe, and the second part will focus on specific types of solid tumors and blood cancers to gather more information about how well the drug works.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of an advanced solid tumor or a specific type of blood cancer that has not responded to existing treatments. Participants will be closely monitored by the research team throughout the study. It's important to note that individuals with certain medical conditions or who are pregnant or breastfeeding cannot take part in the trial. If you meet the eligibility criteria and decide to join, you will contribute to important research that could help improve treatment options for people with these challenging cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be ≥18 years of age, at the time of signing the informed consent.
• 2. Dose escalation and expansion:
• • 1. Solid tumors: have a histologically confirmed relapsed or refractory advanced solid tumor for which no standard approved treatment is available, or is ineligible for, or did not tolerate standard approved treatment.
• • 2. NHL: have a histologically confirmed relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or Mantle cell lymphoma (MCL) for which no standard approved treatment is available, or is ineligible for, or did not tolerate standard approved treatment.
• 3. Measurable/evaluable disease or documented relapse, respectively, relevant for tumor type as follows:
• • 1. Solid tumors: per Response evaluation criteria in solid tumors (RECIST) 1.1 with at least one target lesion
• • 2. NHL: Measurable disease defined as ≥1 measurable nodal lesion (long axis \>1.5 cm and short axis \>1.0 cm) or ≥1 measurable extra-nodal lesion (long axis \>1.0 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI)
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• • 5. All previous anti-cancer therapy-related AEs should have resolved to grade 1 or baseline value with the exception of alopecia and stable, treated endocrine toxicities of immune checkpoint inhibitors (ICIs) Note: Subjects with irreversible toxicity that in the opinion of the treating physician is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, hormone deficiency requiring replacement therapy) -
• Exclusion Criteria:
• • 1. Known hypersensitivity to JBZ-001 or any of its excipients
• • 2. Corrected interval between Q and T wave on ECG (QTc) ≥ 470 msec using Fredericia's formula.
• • 3. Has significant and symptomatic cardiovascular disease (such as congestive heart failure New York Heart Association class III or higher, myocardial infarction, cerebrovascular disease, unstable angina, unstable arrhythmia) within the 3 months prior to first dose of JBZ-001.
• • 4. Has another malignant disease requiring treatment, with the exception of curatively treated malignancies or malignancies with very low potential for recurrence or progression.
• 5. For solid tumor subjects:
• • 1. Symptomatic ascites or pleural effusion. A subject who is clinically stable for 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
• • 2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry, as long as the dose is ≤ 4 mg of dexamethasone or equivalent per day
• • 6. Known active HIV infection on antiretroviral therapy. Note: Testing is not required for eligibility.
• • 7. Known active infection with hepatitis B or hepatitis C. Note: Testing is not required for eligibility.
• • 8. Any other active infection requiring systemic therapy.
• • 9. Major surgery (excluding procedures to stabilize the vertebrae) within 4 weeks or minor surgery within 2 weeks prior to first dose of JBZ-001.
• • 10. Has a history of GI surgery or other procedures that might interfere with the absorption or swallowing of the study drug.
• • 11. History or clinical evidence of any medical condition which the investigator judges as likely to interfere with the results of the study, poses an additional risk in participating, or makes the subject unlikely to comply with the study-related visits and assessments.
• • 12. Female participants: pregnant or breastfeeding.